Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial. The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;

• AF duration 1-3 years;

• Age 18 - 75 years;

• Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;

• AF recorded within 3 years of enrollment;

• Patient willing and able to comply with protocol and sign informed consent

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Peking University third hospital
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
NOT_YET_RECRUITING
Shenzhen
Taizhou First People's Hospital
NOT_YET_RECRUITING
Taizhou
Xijing Hospital, Air Force Medical University
NOT_YET_RECRUITING
Xi’an
Zhengzhou University People's Hospital, Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Yan Dong, MD
dy_medical@163.com
+86 18651908170
Backup
Qiushi Chen, MD
chenqs918@163.com
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2027-12
Participants
Target number of participants: 320
Treatments
Experimental: CPVI-MLA
Patients randomized to the CPVI-MLA group first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI).
Active_comparator: CPVI only
Patients randomized to the CPVI group undergo right PV ablation, followed by the left PV ablation. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia in a wide-area circumferential pattern. Complete CPVI is achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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